| CTRI Number |
CTRI/2025/07/091890 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of herbal mouthwash in orthodontic patients |
|
Scientific Title of Study
|
Evaluation Of Effect Of
Syzygium Cumini & Orange Peel Mouthwash On Periodontal Health In Patients Undergoing
Orthodontic Treatment- A Randomized Controlled Trial.
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUREKHA RATHOD |
| Designation |
Professor |
| Affiliation |
Rnajeet Deshmukh Dental College, Nagpur |
| Address |
Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUREKHA RATHOD |
| Designation |
Professor |
| Affiliation |
Rnajeet Deshmukh Dental College, Nagpur |
| Address |
Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre
MAHARASHTRA
440019
India |
| Phone |
09011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUREKHA RATHOD |
| Designation |
Professor |
| Affiliation |
Rnajeet Deshmukh Dental College, Nagpur |
| Address |
Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre
MAHARASHTRA
440019
India |
| Phone |
09011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
self |
| Address |
dept of periodontics , ranjeet deshmukh dental college and research centre |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| sanskruti pusdekar |
Ranjeet deshmukh dental college and research centre |
Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA |
09011071477
drsurekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine gluconate |
.2 percentage 5 ml twice daily |
| Intervention |
herbal mouthwash |
orangepeel and sygygium cumini 5ml twice daily |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
undergoing orthodontic treatment and having PPD and CAL of more than 4 mm |
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone any periodontal therapy in the past 6 months.
2. Patients with systemic diseases.
3. History of any medication including antibiotic treatment within the previous 3 months or regular use of specific drugs known to affect periodontal tissues.
4. Pregnant women and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| plaue index, gingival index |
BASELINE, 1 MONTH, 3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PBI,PPD,CAL |
BASELINE,1 MONTH, 3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Orthodontic treatment plays a crucial role in aligning teeth and improving both function and
aesthetics. However, it can also pose challenges to periodontal health. Common periodontal
complications associated with orthodontic therapy include gingivitis, periodontitis, gingival
recession or hypertrophy, alveolar bone loss, dehiscence, fenestration, interdental folds, and
the formation of dark triangles. The primary factor contributing to these issues is plaque
accumulation, which plays a key role in the initiation, progression, and recurrence of
periodontal disease, particularly in patients with a compromised periodontium. The presence
of orthodontic brackets and elastics can hinder effective plaque removal, increasing the risk of
gingivitis. Additionally, orthodontic treatment alters the balance of oral microflora by
promoting bacterial retention, further exacerbating periodontal concerns. |